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Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01539863
First Posted: February 28, 2012
Last Update Posted: August 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Iben Axen, Karolinska Institutet
February 22, 2012
February 28, 2012
August 18, 2017
March 2012
August 2016   (Final data collection date for primary outcome measure)
number of days with bothersome low back pain [ Time Frame: 12 months ]
Participants will report their number of days with bothersome low back pain via text message (SMS) on a weekly basis for 52 weeks.
Same as current
Complete list of historical versions of study NCT01539863 on ClinicalTrials.gov Archive Site
cost-effectiveness [ Time Frame: 12 months ]
Cost-effectiveness will be based on Quality Adjusted Life Years calculated through the use of the Euroqol-5 instrument
Same as current
Not Provided
Not Provided
 
Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain
Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain. A Randomized Controlled Trial With 1 Year Follow up

As low back pain is often a recurrent and sometime persistent problem, research into prevention is important. Chiropractors have traditionally treated patients with maintenance care, which means that patients are seen on a regular basis to prevent recurrences or to stop a persistent problem getting worse. However, it is not known if this has the expected effect.

This study will test the effectiveness of the maintenance care approach. Patients with recurrent or persistent low back pain will be treated in accordance with two different models. The first model is the maintenance care model, meaning that chiropractors will see the patient on a regular basis, regardless symptoms. The other model means that patients should be treated patients only when they themselves experience symptoms bad enough to seek care. After one year, it will be possible to see if there has been any difference between the groups in terms of pain, disability, quality of life and total number of treatments over the study period and to investigate if there is any difference in the cost-effectiveness between the two treatment models.Thus, the study hypothesis is that there is no difference between the two models regarding the number of days with pain.

This study will be a multi-centre trial, and as part of the study, it will be necessary to formalize a network of research clinics all over Sweden in which participating chiropractors accept to perform complex data collection. This network will then have the expertise and potential to perform future clinical studies together with networks in other countries, allowing large clinical trials across countries.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Recurrent Low Back Pain
  • Persistent Low Back Pain
  • Chronic Low Back Pain
  • Other: maintenance care
    Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor
  • Other: Treatment as needed
    Participants may never receive treatment, there is no upper limit
  • Experimental: Treatment at regular intervals
    Participants will be scheduled to receive the intervention, maintenance care, i.e. care on a regular basis throughout the study period.Care may consist of manual treatment but also of e.g. advice concerning exercises, ergonomic adaptation and stress management
    Intervention: Other: maintenance care
  • Active Comparator: Treatment as needed
    Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration
    Intervention: Other: Treatment as needed

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
321
October 2016
August 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • non-specific low back pain > 30 days previous year
  • non-specific low back pain with previous episodes
  • age 18-65
  • access to a mobile phone
  • knowledge of how to text message
  • proficiency in the Swedish language
  • must rate themselves as "definitely improved" by the 4th visit

Exclusion Criteria:

  • pregnancy
  • contraindication to spinal manipulative therapy
  • liability issues
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01539863
KIIMMIIR
No
Not Provided
Not Provided
Iben Axen, Karolinska Institutet
Karolinska Institutet
Not Provided
Study Director: Irene Jensen, PhD Karolinska Institutet
Karolinska Institutet
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP